Vessel Wall Response of the Zotarolimus Drug-eluting Stent Implanted in AMI Assessed by Optical Coherence Tomography (OCTAMI)

May 17, 2022 updated by: Giulio Guagliumi, A.O. Ospedale Papa Giovanni XXIII

Prospective, Randomized, Controlled Arm Study Comparing the Coverage of the Zotarolimus-eluting Stent vs Bare Metal Stent Implanted in ST- Elevation Myocardial Infarction (STEMI).

The objective of this study is to evaluate the completeness of struts coverage and vessel wall response (strut malapposition, neointima disomogeneities in texture) to the ENDEAVOR drug-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform) implanted for the treatment of the culprit lesion in ST-elevation acute myocardial infarction (STEMI). To investigate the completeness of the coverage as well as the number of uncovered stent struts per section (embedded, uncovered, malapposed) and the neointima texture, high resolution (~ 10-15 µm axial) intracoronary optical coherence tomography (OCT)will be used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Major concerns have been raised with regard to the safety of drug-eluting stents (DES) in patients with ST-elevation acute myocardial infarction (STEMI). Data from registry studies have suggested that implantation of DES during primary PCI could be associated with an increased risk for stent thrombosis, probably due to delayed arterial healing. Unlike first generation DES, zotarolimus-eluting stents seems to be associated with complete and uniform neointimal coverage. The objective of this prospective study is to measure the completeness of strut coverage and vessel wall response to the ENDEAVOR zotarolimus-eluting stent vs the DRIVER stent (bare metal stent of identical metallic platform) implanted in STEMI patients. Optical Coherence Tomography (OCT) that detects smaller degrees of stent strut coverage more accurately than IVUS will be used at 6 months follow-up. Intravascular ultrasound (IVUS) will be performed as per normal practice at any index procedures and at 6 months follow-up.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bergamo, Italy
        • Ospedali Riuniti di Bergamo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute Myocardial MI with ST segment Elevation, within 12 hours from symptoms onset
  • Native coronary artery disease with >70% diameter stenosis (no prior stent implant, no prior brachytherapy)
  • Vessel size in between 2.5 and 3.75 mm
  • Signed patient informed consent

Exclusion Criteria:

  • Lesions in coronary artery bypass grafts
  • Significant left main disease
  • Killip class IV
  • Reecent major bleeding (6 months)
  • Renal failure with creatinine value > 2.5 mg/dl
  • Allergy to aspirin and or clopidogrel/ticlopidine
  • Patient in anticoagulant therapy
  • IMA due to a stent thrombosis
  • No suitable anatomy for OCT scan: (only ostial location, very tortuous anatomy, very distal or large vessels [≥ 3.75 mm in diameter])

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: DES - Zotarolimus Drug eluting stents
Zotarolimus Drug eluting stents in overlap
Device: ENDEAVOR® drug-eluting stent (Medtronic, Santa Rosa, CA)
ENDEAVOR® drug-eluting stent implanted in acute myocardial infarction
Device: Coronary stent implantation
Comparison of Drug Eluting versus Bare Metal Stent
Other Names:
  • Zotarolimus Eluting Coronary Stent
ACTIVE_COMPARATOR: BMS -Bare metal stent
Bare metal stent
Device: DRIVER bare metal stent (Medtronic, Santa Rosa, Ca)
DRIVER bare metal stent implanted in acute myocardial infarction
Device: Bare Metal Coronary Stent
Comaprison between Drug Eluting and Bare Metal Coronary Stents
Other Names:
  • Driver Coronary Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non inferiority OCT Number of uncovered Stent struts for Endeavor drug eluting stent vs Driver BMSbare metal stent
Time Frame: 6 months
Non inferiority
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of well apposed stent struts without neointima
Time Frame: 6 months
number of well apposed stent struts without neointima
6 months
number of malapposed stent struts without neointima
Time Frame: 6 months
number of malapposed stent struts without neointima
6 months
number of sections with > 30% uncovered struts/total struts
Time Frame: 6 months
number of sections with > 30% uncovered struts/total struts
6 months
Number of sections with incomplete strut apposition
Time Frame: 6 months
Number of sections with incomplete strut apposition
6 months
Adjudicated MACE(Death, re-MI, TLR) rate at 30 days and 6 months (non inferiority)
Time Frame: 6 months
Adjudicated MACE(Death, re-MI, TLR) rate at 30 days and 6 months (non inferiority)
6 months
In segment OCT neontimal volume
Time Frame: 6 months
In segment OCT neontimal volume
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A.O. Ospedale Papa Giovanni XXIII

Collaborators

Medtronic
Case Western Reserve University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

June 24, 2008

First Submitted That Met QC Criteria

June 24, 2008

First Posted (ESTIMATE)

June 25, 2008

Study Record Updates

Last Update Posted (ACTUAL)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 457/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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